This page gives information about a clinical trial called LACEWING. It will help you learn what you need to know about being in it.

To learn more, click below.

About the LACEWING clinical trial

Who is this clinical study for?

Adults with newly diagnosed acute myeloid leukemia or AML who:

have a FLT3 gene mutation

cannot receive standard chemotherapy

Study Title

A study of ASP2215 (gilteritinib) by itself, ASP2215 combined with azacitidine or azacitidine by itself to treat adult patients who have recently been diagnosed with acute myeloid leukemia with a FLT3 gene mutation and who cannot receive standard chemotherapy

Keep in mind that people who are in the study may choose to stop at any time.

Things to think about before being part of a clinical trial

Being part of a clinical trial takes time and effort for people in it and their caregivers. Here is important information you should know about the LACEWING clinical trial:

Clinic Visits

The number of clinic visits. Number of visits may be different for each participant. You can talk to the study doctor to learn more.

Month 2

2 visits

Month 1

Up to 7visits

Month 3+

1 visit/month

What do you need to know about the study?

Conditions being studied

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia with FMS-like tyrosine kinase (FLT3) mutation

Drugs being tested in the study

The drugs that are being studied, separately or together, in this clinical trial.

gilteritinib

azacitidine

Facts about the study

Clinical trials happen in phases. Each phase has a different goal that helps researchers answer specific questions. For example, in Phase 2, the goal is to find out if the medicine works and learn more about its safety. In Phase 3, the goal is to test the medicine compared to different treatments. Also, researchers can learn more about the medicines side effects and how to use it safely.

Trial phase

3

Searching for

323

participants

What can you expect from being in this study?

Being part of the LACEWING clinical trial takes time and effort for the person in it and their caregiver. You may:

be in the study for several years

need to travel to the clinical trial site location

receive shots, infusions, or pills you take by mouth

need blood taken or other tests such as heart monitoring. This helps researchers learn how the medicine is working

This medicine is experimental. Because of that, the effectiveness has not been established and not all risks are known before starting the clinical trial. Furthermore, you may experience side effects from the clinical trial treatment. People who are in the study may choose to stop at any time.

Why is this study being done?

This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster. This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

Could you be a good fit for this study?

Answer these questions to learn more.

Did your doctor say you have AML and has not yet started treating you for it?

YESNOI don't know

Have you tested positive for the FLT3 gene mutation? (Answer "I DON'T KNOW" if you have not been tested or you don't know the result of the test).

YESNOI don't know

Are you 75 years or older?

YESNO

Do you have congestive heart failure? This is when the heart does not pump blood as well as it should.

YESNOI don't know

Do you have any of these medical conditions: kidney disease, kidney transplant or getting dialysis treatment?

YESNOI don't know

Have you ever had cancer in the past?

YESNOI don't know

Based on your answers, you may be a good fit for this study.

A study doctor at the clinical trial center will determine if you qualify for the study.

To learn more about being in the study, contact a clinical trial center.To find the clinical trial center closest to you, enter your location below.

Based on your answers, this study may not be right for you. Please talk to your doctor if you still have questions about the LACEWING study. Or, if you still think you may be a good fit for this clinical trial, search below for a clinical trial center near you. You can contact the doctor who is leading the study and speak with them.

Please answer all questions before searching for clinical trial centers.

Clinical trial centers closest to you

Location

Address could not be found.

Preferred Distance

10 miles

25 miles

50 miles

100 miles

200 miles

If you are having trouble contacting a clinical trial center or if you have other clinical trial questions, please call the Astellas Medical Information team at 1 (800) 727‑7003.We are available Monday–Friday, 8:00 AM–4:30 PM CT.